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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Agitator — Class IIa MDR by Calyx Medical Sp. z o.o.

MD Atlas
Calyx Medical Sp. z o.o.

EUDAMED last updated this device on Mar 1, 2024

Agitator

59061689422URO059LJ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Calyx Medical Sp. z o.o.
UDI-DI code: 05906168942266
Reference / catalog number: URO 059

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View device family (Basic UDI)

Manufacturer information

Organization name: Calyx Medical Sp. z o.o.
SRN: PL-MF-000038787
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Dec 2, 2024	Still on market

Device identification

Trade name: Agitator
UDI-DI code: 05906168942266
Basic UDI-DI: 59061689422URO059LJ
Reference / catalog number: URO 059
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Agitator - Irrigation Steerable Catheter (Agitator) is a Fr 6 steerable catheter that directs a bolus of irrigation fluid towards stone fragments, making them temporarily waterborne.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05906168942266

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z12099099VARIOUS NEPHROLOGY AND HAEMODIALYSIS INSTRUMENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.